Kornimate/medical-research-clean huggingface dataset:
a cohort study to assess sustained immunogenicity to qhpv vaccine among hiv-infected girls and boys age 9-14 years

Conditions: Human Papillomavirus; HIV-1 Infection

Summary: the purpose of this study is to determine sustained immunogenicity of the quadrivalent vaccine 'gardasil', 48 months after initial vaccination, among hiv-1 infected boys and girls age 9-14 years. this age range is within the world health organization (who) stipulated guidelines for national programs for the vaccine.

hiv-infected individuals bear a disproportionate disease burden of hpv-related diseases suggesting more rapid progression from hpv acquisition to malignancy. hiv infected women have a 2-22 fold increased risk for cervical cancer compared to uninfected women. the quadrivalent hpv vaccine marketed as "gardasil" has demonstrated efficacy against type specific hpv infections known to cause 70% cervical cancer (hpv 16 \& 18) and hpv 6 \& 11 known to cause 90% of anogenital warts in populations of hiv negative young women. since the risk of hpv exposure persists throughout a person's sexual life, the duration of protection, especially when the vaccine is given in the pre-adolescent period, is critical to overall vaccine effectiveness. extended follow up of hiv-uninfected individuals has shown sustained response to hpv vaccine for 8.4 and 6 years respectively to the bivalent and quadrivalent vaccines. however, other vaccines such as the hepatitis b vaccine have been shown to require additional dosages to be effective among hiv-infected persons. data on immunogenicity of the hpv vaccine among hiv infected adolescents is limited to a 12 month follow up period. current hpv vaccine guidelines target pre-sexual adolescents. since the risk of hpv exposure persists throughout an individual's sexual life, the duration of protection provided by vaccination is critical to the overall vaccine effectiveness. duration of sustained hpv 6/11/16/18 antibody response is directly related to vaccine effectiveness and determines the need for booster dosing. the investigators therefore propose to extend follow up of 179 girls and boys in kenya, age 9-14 years who have received 3 doses of the quadrivalent 'gardasil' vaccine and assess for immunogenicity annually. study location: partners in prevention, thika site

Eligibility criteria:
inclusion criteria: * hiv-infected * age 9-14 years * guardian/parental consent exclusion criteria: participants will be excluded if they * are severely ill as defined by karnofsky \<70 * have a diagnosis of malignancy * on-going febrile illness (temperature ≥37.8°c), including active treatment for an opportunistic infection * have received systemic corticosteroids within prior one year * have received inactivated vaccine within prior 2 weeks, or live attenuated vaccine within prior 6 weeks * have history of allergy to any products included in the hpv vaccine * have received any of blood derivatives within prior 6 months * are pregnant * lack parental consent and/or parent declines to provide assent

Keywords: quadrivalent vaccine human papillomavirus
expiratory muscle training and trunk flexion in parkinson's disease

Conditions: Parkinson Disease

Summary: postural abnormalities involving the trunk are prevalent in over 20% of patients with parkinson's disease (pd). pathological forward trunk flexion (ftf) is a drug-refractory complication in patients with pd leading to imbalance, pain and fall-related injuries. deep abdominal muscle training is a key rehabilitation strategy for ftf, as muscles like the transversus abdominis and multifidus are crucial for lumbar stabilization. this training has been shown to improve body position and lumbar proprioception. abdominal muscles are also responsible for forced expiration. expiratory muscle strength training (emst) utilizing forced expiration through expiratory trainer has emerged as a beneficial intervention in the non-pharmacological management of pd, positively impacting clinical aspects such as dysphagia, dystussia, hypokinetic dysarthria, and drooling. emg study showed large abdominal muscles activity, particularly the transversus abdominis and internus obliquus abdominis during emst. therefore, emst might also be effective in improving lumbar stabilization. given the established role of abdominal muscles in trunk stabilization, it is plausible that activation of deep abdominal muscles during emst with the right level of resistance might improve ftf in pd patients. no studies have yet examined the effect of emst on posture in pd. the primary aim of this study will be to evaluate the effect of emst on forward trunk flexion in patients with parkinson's disease. the secondary aim will be to assess the potential duration of the emst effect on postural abnormalities and its impact on patient stability.


Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease * age ≥ 18 years * moca (montreal cognitive assessment) score ≥19 * pathological forward trunk flexion defined as thoracic (≥25°) or lumbar (\>15°) flexion during standing and walking, which completely disappears in the supine position. exclusion criteria: * severe dyskinesia or "on-off" fluctuations * change in the pd medication in the last 3 months prior to enrollment * history of major spinal surgery or musculoskeletal spinal disorders * need for assistive devices when rising from a chair or bed * other neurological, orthopedic, or cardiovascular comorbidities that could affect postural control * inadequate lip seal.

Keywords: parkinson disease expiratory muscle strength training forward trunk flexion
acute kidney injury after cardiac surgery on cpb

Conditions: Acute Kidney Injury; Congenital Heart Disease; Surgery; CBP; Child, Only

Summary: the purpose of this retrospective study is to determine the incidence and severity of acute kidney injuries (aki) after heart surgery on cardiopulmonary bypass (cpb) in the pediatric intensive care unit (picu) in lausanne, switzerland.

the investigators will review in a retrospective way, all patients aged between 0 and 16 years, admitted in the picu after cardiac surgery on cpb from 01.01.2014 to 31.12.2016. they will asses for aki. the first step is to determine the incidence and severity, the second step is to determine the risk factors for aki and/or protecting factors.

Eligibility criteria:
inclusion criteria: - all pediatric patients (0-16 years) admitted to picu after cardiac surgery with cpb. exclusion criteria: * preexisting kidney injury, * no preoperative creatinine lab value

Keywords: acute kidney injury, aki
diagnostic accuracy of multi-detector spiral computed tomography angiography using 64 detectors

Conditions: Coronary Artery Disease

Summary: to compare the diagnostic ability of 64-detector mdct coronary angiography with conventional invasive coronary angiography in patients with suspected coronary artery disease.

the "coronary evaluation using multidetector spiral computed tomography angiography using 64 detectors" or "core-64" study was designed to evaluate the diagnostic accuracy of multislice spiral ct angiography using 64 detector rows for identifying coronary artery stenosis in patients with suspected or known coronary artery disease. the study was designed as a prospective, multi-center, international, blinded study examining the diagnostic accuracy of 64-slice ct in comparison with cca. the primary hypothesis of the study is that 64-slice ct coronary angiography will be able to detect significant coronary artery disease in a patient with acceptable diagnostic accuracy as compared to cca. significant cad is defined as ≥ 50% stenosis as determined by quantitative analysis of cca (qca). the diagnostic parameters is per-patient sensitivity and specificity compared with cca, with both point estimates and continuous measurements of diagnostic accuracy. eligible patients will first undergo mdct (calcium scanning and mdcta)prior to clinically indicated conventional coronary angiography. patients with cac 600 or less will be included in the primary analysis. patients will be followed for clinical events including revascularization.

Eligibility criteria:
inclusion criteria: * male or female patients, age 40 years or greater. * women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study mdct. * suspected coronary artery disease (i.e. symptoms, signs) with a clinical indication for coronary angiography; and planned coronary angiography within the next 30 days. * able to understand and willing to sign informed consent. exclusion criteria: * known allergy to iodinated contrast media * history of contrast-induced nephropathy * history of multiple myeloma or previous organ transplantation * elevated serum creatinine (\> 1.5mg/dl) or calculated creatinine clearance of \< 60 ml/min (using the cockcroft-gault formula * atrial fibrillation or uncontrolled tachyarrhythmia, or heart block * evidence of severe symptomatic heart failure; moderate or severe aortic stenosis * previous coronary artery bypass or other cardiac surgery * coronary artery intervention within the last 6 months * intolerance or contraindication to beta-blockers * body mass index \> 40.

Keywords: coronary artery disease computed tomography angiography
a retrospective, observational study on the effectiveness of daclatasvir-containing regimens in patients in ksa, uae and qatar

Conditions: Hepatitis C

Summary: the study will provide safety and efficacy information among patients receiving daclatasvir. it will describe daclatasvir prescribing patterns and provide a clinical profile of patients receiving the treatment in ksa, uae, and qatar.


Eligibility criteria:
inclusion criteria: * adult patients greater than or equal to 18 years of age * diagnosed with chronic hepatitis c * ended treatment with daclatasvir-containing regimen no later than 01-oct-2015 exclusion criteria: * use of a daclatasvir-containing regimen in a clinical trial setting other protocol defined inclusion/exclusion criteria could apply
safety and effectiveness study of docetaxel and zd1839 followed by removal of the prostate to treat prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine the safety and effectiveness of the combination of docetaxel and zd1839 on destroying prostate cancer before removal of the prostate.

it is recognized that there is a subset of patients who are at high risk for progression despite aggressive treatment of localized disease at the time of detection. the critical issue is in addressing micrometastatic disease that has already developed prior to diagnosis. this study utilizes daily doses of zd1839 and weekly docetaxel for two cycles prior to radical prostatectomy. zd1839 has demonstrated antiproliferative activity against human tumor xenografts and in coadministration with cytotoxic agents against prostate cell lines (pc-3 and tsu-pri). the combination of zd1839 and docetaxel has been reported to be feasible with an acceptable toxicity profile. this phase ii, single center trial is specifically targeting those patients with high-risk adenosarcoma of the prostate.

Eligibility criteria:
inclusion criteria: * prostate carcinoma: clinical stage t2b-3 or serum psa\>20 ng/ml or gleason sum score 8-10. * clinical t2 patients are eligible if endorectal coil mri shows t3 disease, or gleason 4+3 cancer in 5 or more biopsies (minimum of 10 biopsies total required) * ecog performance status of 0, 1 or 2 * adequate hematological, liver and renal function * existing peripheral neuropathy \< grade 1 * ability to tolerate oral medications. exclusion criteria: * concurrent or prior treatment with radiation, cytotoxic, biologic therapy for prostate cancer * any major surgery within four weeks * prior hormonal therapy (except finasteride for obstructive voiding symptoms- -evidence of metastatic disease, confirmed by physical examination, computed tomography of the abdomen and pelvis within 45 days and by bone scan within 60 days of signing informed consent

Keywords: high risk adenocarcinoma prostate cancer neoadjuvant
retrospective database study of real world abilify outcomes in major depressive disorder (mdd)

Conditions: Depressive Disorder, Major

Summary: to examine the differences in health care utilization and costs between mdd patients on adjunctive aripiprazole therapy and mdd patients on other augmentation therapies.


Eligibility criteria:
inclusion criteria: * ≥1 fill for an augmentation therapy medication from table 1 during the identification period of 01 january 2005 - 30 november 2008. * 12 months of continuous enrollment with medical and pharmacy benefits each before the index date (pre-index period) and after the index date (post-index period). * ≥1 medical claim with a primary international classification of diseases, 9th revision, clinical modification (icd-9-cm) diagnosis for mdd (296.2x, 296.3x, 311.xx) during the pre-index period. * age ≥18 years as of the year of the pre-index period. exclusion criteria: * no pharmacy claims for atypical antipsychotics, mood stabilizers, anxiolytics, anticonvulsants, or stimulants, during the pre-index period. * no medical claims with primary or secondary diagnoses for non-mdd episodic mood disorders or schizophrenia during the pre-index or post-index periods.
readi (readiness evaluation and discharge interventions) study

Conditions: Discharge Transition of Patients Discharged to Home

Summary: preparation of patients for discharge is a primary function of hospital-based nursing care and readiness for discharge is an important outcome of hospital care. inadequacies in discharge preparation have been well-documented and linked to difficulty with self-management after hospital discharge and with increased likelihood of emergency department (ed) use and readmission. prior studies by the research team have led to recommendations for implementation of discharge readiness assessment as a standard nursing practice for hospital discharge. the investigators will conduct a multi-site study to determine the impact on post-discharge utilization (readmission and ed visits) and costs of implementing discharge readiness assessment as a standard nursing practice for adult medical-surgical patients discharged to home. the study tests, in a stepped approach, the impact of implementing discharge readiness assessment by the discharging nurse as standard nursing practice (rn-rhds protocol), the incremental value of informing the nurse assessment with the patient's perspective (rn-rhds+pt-rhds protocol), and of requiring that the nurse initiates and documents risk-mitigating actions for patients with low readiness scores (rn-rhds+pt-rhds+niaf protocol). hypothesis 1: patients discharged using the rn-rhds protocol will have fewer hospital readmissions and ed visits within 30 days post-discharge compared to patients discharged under usual care conditions. hypothesis 2: patients discharged using the rn-rhds+pt-rhds protocol will have fewer hospital readmissions and ed visits within 30 days post-discharge compared to patients discharged using the rn-rhds protocol. hypothesis 3: patients discharged by nurses using the rn-rhds+pt-rhds protocol plus a nurse-initiated action form \[niaf\] (rn-rhds+pt-rhds+niaf protocol) will have fewer post-discharge readmissions and ed visits than patients discharged using the rn-rhds+pt-rhds protocol; the effect will be strongest for patients with low rhds scores. aim 4: conduct cost-benefit analysis of implementing discharge readiness assessment as standard practice, by comparing cost-savings from reduced post-discharge utilization against implementation costs.


Eligibility criteria:
inclusion criteria: * medical, surgical, or medical-surgical nursing units of magnet designated hospitals * patients 18 years of age or more, english speaking,able to read and understand consent who are being discharged to home as the discharge destination. * nursing personnel (registered nurses or licensed practical nurses) who are performing discharge instructions and procedures on the day of hospital discharge. exclusion criteria: * patients discharged to home with hospice care.

Keywords: hospital discharge discharge readiness readmission emergency department visits nurse assessment
68ga-dotatoc for imaging of neuroendocrine tumors: expanded access trial

Conditions: Neuroendocrine Tumors

Summary: the purpose of this study is to use a new type of scan, called 68ga-dotatoc pet/ct scan, instead of octreoscan, the standard scan, to diagnose, monitor and manage your tumor. 68ga-dotatoc is an improved imaging agent being routinely used in many centers outside the usa, with better tumor detection than with octreoscan.


Eligibility criteria:
inclusion criteria: * patients diagnosed or suspected net requiring 111in-pentetreotide imaging for clinical indications. * high risk of net because of familial predisposition with clinical findings requiring radiolabeled somatostatin imaging. * other somatostatin positive tumor for which 111in-pentetreotide has been used successfully (for example adult meningioma). * ability of subject or legally authorized representative (lar) (if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) to understand and the willingness to sign a written informed consent. exclusion criteria: * pregnant or lactating women: pregnant women are excluded from this study because the effects of 68ga-dotatoc in pregnancy are not known; exceptions may be performed if expected risk outweighs the benefit. pregnancy testing will follow mits procedure for diagnostic reagents. patients self report pregnancy status. if pregnant the test will not be performed unless in the clinical opinion of the attending physician the gain of the test is likely to outweigh the risk (this will be rare). if unsure whether pregnant or not then a urine or serum pregnancy will be performed. * because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 68ga-dotatoc in the mother, breastfeeding should be discontinued for at least one day if the mother receives 68ga-dotatoc. * patients that have contraindications for 111in-pentetreotide. * known severe allergy or hypersensitivity to oral contrast will preclude administration of such contrast (will preclude receiving oral contrast only). * patients with a body weight of 400 pounds or more or not able to enter the bore of the pet/ct scanner due to bmi, because of the compromise in image quality with ct, pet/ct and mri that will result. * any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.

Keywords: 68ga-dotatoc pet/ct scan 14-226
heart rate changes following the administration of sugammadex

Conditions: Bradycardia

Summary: this a prospective study when the clinician decides to use sugammadex, heart rate will be recorded every minute for 15 minutes following its administration. if bradycardia occurs and a clinical decision is made to treat it, the medications and doses used will be recorded.


Eligibility criteria:
inclusion criteria: * patient age 0-18 years * anesthetic plan includes nmb reversal with sugammadex exclusion criteria: * sugammadex not used during the case
the heidelberg engineering anterion imaging agreement study

Conditions: Eye Abnormalities; Normal Eyes

Summary: this is a prospective clinical study that will be conducted at one clinical site located in the united states to assess image quality of acquired biometry images of the eye

the conducted study is a non-interventional study for an imaging device used in the aid of ophthalmology diagnosis. because the study is not interventional, the study is not an applicable clinical trial per clinicaltrials.gov definition.

Eligibility criteria:
inclusion criteria: 1. age 22 years or older 2. able and willing to undergo the test procedures, sign informed consent, and follow instructions 3. able to fixate 4. with eye pathology status for each of the two eye populations. a. eye with normal anterior segment b. eyes with anterior segment abnormalities identified with the slit lamp exam including but not limited to: * glaucoma surgeries: trabeculectomy, laser peripheral iridotomy and drainage devices * corneal surgeries: corneal inlays and corneal transplants * pterygium and corneal scar exclusion criteria: 1. subjects which were enrolled in the b-2018-1 study 2. physical inability to be properly positioned at the study devices or eye exam equipment 3. contact lenses worn during imaging
extracorporeal shockwave therapy for the treatment of advanced angina pectoris

Conditions: Refractory Angina Pectoris

Summary: low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones. the hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.

low intensity shockwaves (1/10 the ones used in lithotripsy) are delivered to myocardial ischemic tissue. shockwaves are created by a special generator and are focused using a shockwave applicator device. the treatment is guided by standard echocardiography equipment. the shockwaves are delivered in synchronization with patient r-wave to avoid arrhythmias. the treatment is painless. at first, the patient undergoes stress-spect testing to identify the ischemic areas. following that, the same area is localized by the ultra-sound device and the shockwaves are focused to the ischemic area. several treatment session (9 in total, spread over 9 weeks) are required for optimal results.

Eligibility criteria:
inclusion criteria: * patient is diagnosed with chronic stable angina pectoris, for a period of at least 3 months. diagnosis is based on medical history, complete physical evaluation. * patient has documented myocardial segments with reversible ischemia. * patient is classified in ap ccs of iii-iv. * patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment. * patient demonstrates exercise tolerance capacity of no higher than 125 w on a modified bruce treadmill exercise test until presence of clinical symptoms (i.e. angina, st-depression). * patient demonstrates exercise tolerance time and stability averaging no more than 25% of each other (the tests will be performed within two weeks and at least a day different between the two). * patient has documented epicardial coronary artery disease not amenable to angioplasty or cabg. * patient has signed an irb approved informed consent form. * patient's condition should be stable and should have a life expectancy of \>12 months. patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's) medical opinion. exclusion criteria: * patient is pregnant * patient has chronic lung disease including emphysema and pulmonary fibrosis. * patient has active endocarditis, myocarditis or pericarditis. * patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization, or any eswt machine of a competitor company within 3 months of entry into the study. * patients who are unwilling or unable to cooperate with study procedure

Keywords: extracorporeal shockwave therapy myocardial ischemia refractory angina